ENDURANCE 2521-00-503Recalls & reported problems
Depuy Orthopaedics, Inc. · ENDURANCE VERSION CONTROL GUIDE · Class 1
All models of ENDURANCE (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295127802), received between Apr 4, 2019 and Dec 4, 2024 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Break” (7 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break7
- Component Missing1
- Crack1
- Device Slipped1
Patient problems
- No Consequences Or Impact To Patient5
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 4, 2024Break; Break
IT WAS REPORTED THAT PATIENT UNDERWENT HIP SURGERY ON NOVEMBER 20, 2024. DURING THE PROCEDURE A HANDLE BROKE AS THE DOCTOR CLASPED THE TRIAL TO REMOVE IT FROM THE FEMUR. A VICE GRIP WAS USED TO REMOVE THE TRIAL. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FIVE MINUTE DELAY.
Patient problems: Insufficient Information
MAUDE report 20843480 ↗MalfunctionOct 15, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENT IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20449932 ↗MalfunctionJun 13, 2022Break; Break
IT WAS REPORTED THAT THE WHITE PLASTIC PIECE DISCOVERED BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14676880 ↗MalfunctionNov 12, 2020Break; Break
ENDURANCE VERSION CONTROL GUIDE BROKE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10832094 ↗MalfunctionJul 14, 2020Break; Break
WHITE PLASTIC PIECE BROKE OFF WHILE ATTACHING IMPLANT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10271891 ↗MalfunctionJun 12, 2020Crack; Crack
ENDURANCE INSERTED WAS VISIBLY CRACKED ON THE WHITE SILICONE PORTION. WAS FOUND AFTER THE CASE BY MDRD.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10148295 ↗MalfunctionApr 21, 2020Break; Device Slipped; Component Missing; Break; Device Slipped; Component Missing
3 OF THE ITEMS HAVE CRACKED HANDLES, ONE OF THE 920010029 HANDLES IS JAMMED. THE 252100503 HANDLE IS MISSING A CLIP RENDERING IT UNUSABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9982112 ↗MalfunctionApr 4, 2019Break; Break
STEM INSERTER BROKE. DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? --> NO. PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8483841 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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